Triple Negative Breast Cancer
Conditions
Interventions
experimental group:Camrelizumab combined with chemotherapy
Sponsors
Henan Tumor Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Female patients aged from 18 years to 65 years; 2.ECOG score: 0-1 point; 3.Pathologically diagnosed inoperable locally advanced or metastatic three-negative breast cancer; TNBC patients who had previously received taxa monotherapy and no chemotherapy or targeted therapy during metastatic TNBC allowed patients to receive radiotherapy and chemotherapy, including the adjuvant therapy phase, requiring >= 12 months from the last treatment. Note: ER and PR negative were defined as 10% of cell = 1.5x10^9/L, PLT >= 90x10^9/L; Hb >= 90g/L; (2) Biochemical examination shall meet the following standards: TBIL = 50 mL/min (CockcroftGault formula); (3)The criteria for coagulation tests should be as follows: International standardized ratio (INR) or prothrombin time (PT) = 55% ); (5) ECG Fridericia-corrected QT Interval (QTcF) Female < 470 ms; 6.Subject provided a core biopsy from tumor lesions to confirm TNBC status and biomarker analysis before therapy began; 7.For women without menopause or surgical sterilization: agree to abstinence or use effective contraception during treatment and at least 7 months after the last administration in the study treatment; 8.The patient volunteered to participate in the study and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Previous treatment with anti PD-1, anti PD-L1, anti PD-L2 drugs or for another co-inhibitory T cell receptor (such as CTLA-4,OX-40, CD137); 2.Also receiving anti-tumor therapy in other clinical trials, including endocrine therapy, biphosphate therapy, or immunotherapy; 3.Significant breast cancer-unrelated surgery within 4 weeks prior to entry, or the patient has not fully recovered from such surgery; 4.Severe heart disease or discomfort, including but not limited to the following diseases: (1)History of heart failure or systolic dysfunction (LVEF 100 bpm, significant ventricular arrhythmia (e. g. ventricular tachycardia) or higher level atrioventricular block (i. e. Mobitz II second or third degree atrioventricular block); (3)Need Antiangina medication for angina; (4)Valvular heart disease with clinical significance; (5)ECG shows transwall myocardial infarction; (6)Hypertension control (systolic> 180 mmHg and / or diastolic pressure> 100 mmHg); (7)Severe or uncontrolled disease or active infection (Class >= CTCAE 2 infection) that the investigator believes will increase the risk associated with study involvement, study drug administration or affect the subject's ability to receive the study drug; (8)Renal failure requires hemodialysis or peritoneal dialysis; (9)Subjects who had and present interstitial lung disease, pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, and severe impaired lung function may interfere with the detection and treatment of suspected drug-related lung toxicity; (10)Family adenoma disease colon polyposis (FAP), hereditary non-polyposis colorectal cancer (HNPCC), active Crohn's disease or active ulcerative colitis, current gastrointestinal diseases (including incomplete intestinal obstruction) or researchers who may cause gastrointestinal bleeding, perforation or obstruction; (11)Had any bleeding event, Class >= CTCAE 3 , with an unhealed wound, ulcer or fracture; (12)Had dynamic/venous thrombosis events within 3 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep venous thrombosis, and pulmonary embolism; (13)Suffer from autoimmune diseases or requires full corticosteroids or immunosuppressive drugs, other diseases treated by the body (physiological corticosteroid alternative therapy that allows adrenal or pituitary insufficiency), including HIV-positive or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation; (14)Patients with significant malnutrition; eliminate if the patient is receiving intravenous nutrient fluids or requires hospitalization for continuous infusion; patients with good nutritional control of >= 28 days before entry; 5.Participants who received live/attenuated vaccines within 30 days of the first treatment; 6.Patients were not recommended for allergies or with contraindications to any study drug in the chemotherapy regimen; 7.Women with pregnancy and lactation, women with fertility and tested positive for the baseline pregnancy test, or patients of childbearing age who were not willing to take effective contraception during the whole trial period and 7 months after the final study medication; 8.According to the researchers' judgment, there are accompanying diseases that seriously endanger the patient's safety or affect the completion of the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free-Survival;overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Duration of Response; | — |
Countries
China
Contacts
Public ContactGuo Hongqiang
Henan Tumor Hospital
Outcome results
None listed